Zohydro, The Latest Opioid Painkiller: How The FDA May Be Catalyzing Drug Addiction

Drug overdose death rates more than tripled over the past 20 years, yet that didn't stop the FDA from approving a high-dose opioid painkiller. Now, health groups are fighting back.
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In case you haven’t heard, the U.S. is currently going through a prescription drug epidemic, caused by an amalgamation of various factors. Drug users’ increased tolerance, inconsistent efforts to control the drugs’ spread, and unnecessary prescribing opioid painkillers are just some reasons. But although drug overdose deaths have more than tripled since 1990, the Food and Drug Administration (FDA) made a peculiar decision last year to approve a brand new opioid painkiller “that’s somewhere in the neighborhood of five times more potent than what we’re dealing with now,” Dr. Stephen Anderson, a Washington emergency room physician, told CNN.

Called Zohydro ER is an extended-release opioid analgesic. It’s the first single-entity opioid painkiller, meaning that its main ingredient, hydrocodone, is not combined with another non-opioid painkiller like acetaminophen or ibuprofen. It was approved by the FDA in October to treat pain “severe enough to require daily, around-the-clock, long-term treatment, and for which alternative treatment options are inadequate,” an FDA statement said.

But at its highest dose of 50 milligrams, it’s five times higher than the highest dose of Vicodin. A single capsule can kill a child. Two can kill an adult, a group of more than 40 health care, consumer, and addiction treatment organizations wrote in a letter to the FDA’s Commissioner Margaret A. Hamburg urging the agency to revoke its approval. “In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high dose opioid,” they wrote.

Between 1997 and 2007, milligram-per-person use of prescription opioids rose from 74 milligrams to 369 milligrams, and retail pharmacies dispensed 48 percent more opioid prescriptions between 2000 and 2009. And these rates correlate to, what the authors say, is a 415 percent and 265 percent increase in opioid deaths. The letter “implores” the FDA to review its approval, noting that other recently approved high-dose opioids killed thousands of lives.

Why Did The FDA Approve Zohydro?

It’s still unclear why exactly the agency approved the drug. The authors of the letter believe it was because of industry interests. But many things are clear.

The FDA relies on an advisory panel of doctors, pharmacologists, and scientists to examine drug trial data and vote on whether a drug should be approved. While the agency almost always goes with the panel’s decision, it didn’t with Zohydro. In a surprisingly odd turn, the FDA still approved the drug despite an 11-2 vote against its approval.

One concern for the panel and many others, is that the drug can be easily crushed, just like the original version of OxyContin — making it easy to snort. Newer versions of other opioids have been created with tamper proof coating. The panel also felt that the consequences of taking it for longer than 12 weeks had not been “well studied,” Dr. Judith Kramer, a panelist and professor at Duke University Medical Center, told MedPage Today. Furthermore, the drug’s maker, Zogenix, didn’t offer any “remedy on how it would limit” the drug’s “unintended use,” consumer representative Rodney Mullins, told MedPage Today.

The FDA approved the drug in a strange fashion too: Approving it a day after announcing that it would shift hydrocodone-containing drugs from a schedule III to schedule II controlled substance. But in its defense, approving it as a schedule II controlled substance meant that the drug would be highly limited in terms of how it’s prescribed. Schedule II drugs can only be given through a physician’s written prescription, and there are no refills allowed. Also, the FDA said that the approval of the drug would require new labeling, stronger warnings, and post marketing studies to assess the risks of abuse and hyperalgesia, among other things.

The FDA and Zogenix believe that Zohydro will only be prescribed to patients with severe pain, who have exhausted other options. But, according to Dr. Sanjay Gupta, a neurosurgeon and CNN’s chief medical correspondent, the “truth is, it’s easier for a doctor to write a prescription than to explore other effective options to combat pain. And it is easier for patients to take those prescription pills that to search for alternatives themselves. Both those things must absolutely change,” he wrote in an editorial about the epidemic.